a study of secukinumab treatment in patients with plaque psoriasis and coexisting non-alcoholic fatty liver disease (nafld)

Conditions: Plaque Psoriasis; Non-alcoholic Fatty Liver Disease

Summary: the aim of this study was to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic triglyceride content) and anti-fibrotic (reduction of hepatic fibrosis) effects of secukinumab in patients with psoriasis and coexisting non-alcoholic fatty liver disease (nafld).

primary outcome measure is percentage of participants achieving ≥ 90% improvement (reduction) in pasi score compared to baseline. psoriasis area and severity index (pasi) 90 response is defined as ≥ 90% improvement (reduction) in score compared to baseline. it is a composite score where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. primary analysis was planned to be performed comparing treatments with respect to the primary efficacy variable in a logistic regression model. it was planned to present the odds ratio and its 95%-confidence interval and p-value. planned null hypothesis to be rejected was that the odds ratio of a pasi90 response for patients with secukinumab vs. patients with placebo is ≥1 after 12 weeks. due to premature termination and limited number of treated patients with available data (7 in the secukinumab group and 3 in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and sd) for the score.

Eligibility criteria:
inclusion criteria: * male/female patients, 18 years or older * moderate to severe plaque-type psoriasis, candidate for systemic therapy * diagnosis of nafld by either ultrasound at screening or liver histology within 6 months before baseline * bmi \> 25 kg/ m 2 * alt 1.2 to 3.0 × uln * mri confirmed liver fat ≥ 8% at screening exclusion criteria: * forms of psoriasis other than chronic plaque-type psoriasis * drug induced psoriasis * pregnant or nursing (lactating) women * women of child bearing potential unless they are using effective methods of contraception * ongoing use of prohibited treatments * previous treatment with biological drug targeting il-17 or the il-17 receptor * past medical history record of infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c prior to screening * unstable weight over the last 6 months prior to screening. * type i diabetes, or uncontrolled diabetes (type i or type ii) defined as hbalc ≥ 10% at screening. * evidence of hepatic decompensation or severe liver impairment or cirrhosis * history of liver transplantation or planned liver transplant or biliary diversion. * presence or history of other liver disease * current, or history of, significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening * prior or planned bariatric surgery * inability or unwillingness to undergo mri of the abdomen * past medical history record of infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c prior to screening

Keywords: plaque psoriasis nafld nash pasi secukinumab non-alcoholic fatty liver disease